FDA to Hold Public Meeting on Opioids
FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.
As part of FDA Commissioner Scott Gottlieb’s commitment to deal with what has been called an opioid epidemic in the United States, the commissioner announced a public meeting to be held July 10–11, 2017. The focus of the meeting will be to gain information from the public on the impact of products that have abuse-deterrent properties.
Products with abuse-deterrent properties are designed to deter abuse, and the companies that make these products are required to conduct studies to provide FDA with data on their effectiveness. At the July meeting, the agency plans to discuss how it can use existing data sources and methods to evaluate real-world use of these products and possibly create new sources and methods for obtaining more data.
“The FDA is committed to looking at all facets of this complex issue and collaborating on various approaches, as there are no simple answers to reverse this epidemic … We need better scientific information to understand how to optimize our assessment of abuse deterrent formulations; and I look forward to a productive discussion on how to best tackle this challenge,” Gottlieb stated in a press release.
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
